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For a printer-friendly version, click here. To access our Biotech/Biopharm catalog of services, click here. Gene Therapy Testing Services AppTec offers GLP/cGMP testing programs for somatic cell, viral, and plasmid DNA-based gene therapies. With many years of experience in providing fully integrated biosafety testing programs for the cell and gene therapy fields, we have supported a number of successful BLA and IND applications. Replication-Competent Viral Vector Testing Sensitive in vitro cell culture assays are used to detect replication-competent viral vectors. AppTec can work with clients to provide custom replication-competent virus detection assays for a particular vector construct. Cell Bank and Viral Bank Safety Testing and Characterization AppTec offers all of the assays mandated by regulatory authorities worldwide for the biosafety analysis and characterization of cells, cell lines and viral banks (stocks) used in gene therapy programs. In addition, custom purity and potency testing is available for viral vector stocks. Vector Purification Process Validation for Viral Clearance Most biopharmaceuticals require viral clearance studies to validate the removal of potential contaminants, such as those from bovine components or from helper viruses (adenovirus in AAV production). AppTec can provide custom design and performance of viral clearance studies for various vector purification processes. Custom Testing Programs for Somatic Cell, Ex Vivo Cell, and Tissue Therapies AppTec can guide you through the process of designing and implementing a unique biosafety testing program that meets the needs of your specific project. Sterility and Mycoplasma Testing Complete sterility and mycoplasma testing services (including mycoplasma PCR) are provided in accor- dance with USP, EP, CFR and Points to Consider guidelines. Biodistribution AppTec offers comprehensive in life capabilities to support biodistribution programs. In addition, using real-time PCR technology, our program provides a powerful tool for evaluating the efficacy and safety of nucleic acid protocols by quantifying the copy number of a DNA or RNA target in a defined set of organs and tissues. Raw Material Testing The introduction of viruses into cultures via animal-derived medium supplements is a concern to the regulatory authorities. AppTec has developed protocols for testing media supplements and cells/harvest fluids for the presence of animal viruses. If you are using animal-derived supplements in any part of your process (i.e., from MCB through Final Product), you may wish to consider testing these supplements and your cell banks for adventitious viruses of animal origin. Molecular Biology AppTec’s extensive molecular biology capabilities include custom replication-competent and adventitious virus detection PCR assays, genetic stability analysis, RNA/DNA isolation and quantification, DNA sequencing, residual DNA, reverse transcriptase assays and copy number determination. Technical and Regulatory Guidance on Gene Therapy Product Testing AppTec’s Technical Services will provide you with the technical and regulatory expertise to assure that your product meets the highest expectations of regulatory authorities worldwide.
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